Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis

NCT01787084 | Completed

• 1 other identifier: TVTR-2012-02
• Study Type: observational
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. Will outcomes observed in a high-risk operable transapical native valve TAVR cohort receiving an Edwards SAPIEN device compare to inoperable patients undergoing alternative access TAVR with the Edwards SAPIEN device experience a reasonably similar incidence of 30 day adverse events?

Conditions

Severe Symptomatic Aortic Stenosis

Keywords

Aortic Stenosis; TAVR

Outcome Measures

Primary Outcomes (2)

• Major adverse cardiac and cerebrovascular events

  Increase in the 30-day risk of adverse events among patients receiving TAVR; Modified 30 day Valve Academic Research Consortium (VARC) Composite Early Safety Endpoint

  30 day

• Mortality

  Proportion of patients who are alive with at least moderate functional improvement (defined as at least 10 point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline) at 1 year after TAVR

  1 year

Secondary Outcomes (1)

• 30-day endpoints for major morbidity

  30 day

Study Arms (1)

Inoperable Patients Alternative Access

Non-femoral delivery (or alternative access) in patients iwht severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis

Device: Edwards SAPIEN Transcatheter Heart Valve

Interventions

Edwards SAPIEN Transcatheter Heart Valve DEVICE

Non-femoral transcatheter delivery of heart valve

Inoperable Patients Alternative Access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study cohort will include all TVT Registry data obtained for inoperable patients age 18 years or older who undergo TAVR for severe aortic stenosis using any non-femoral access approach with an Edwards SAPIEN device between the start date and December 31, 2018

You may qualify if:

• years or older
• Primary indication is symptomatic primary severe aortic stenosis predicted to benefit from relief of valvular stenosis
• Aortic valve area less than 0.8 centimeters squared
• Mean aortic valve gradient greater than or equal to 40 mmHG
• Peak aortic jet velocity greater than or equal to 4.0 m per second
• Valve sheath access site is femoral, axillary, transapical, transaortic, subclavian or subaxillary
• Patient is judged by the local heart team to be inoperable for Aortic Valve Replacement due to severe chest wall deformities or radiation effects, severe peripheral or aortic vascular disease, or severe systemic disease prohibiting the safe conduct of Cardiopulmonary Bypass (CPB)

You may not qualify if:

• Aortic valve annulus size is less than 18 mm or greater than 25 mm
• Active infectious endocarditis
• Valve in prosthetic valve procedure
• Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure

Sponsors & Collaborators

• The Society of Thoracic Surgeons: lead
• American College of Cardiology: collaborator

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• John D Carroll, MD

  American College of Cardiology

  PRINCIPAL INVESTIGATOR

• Fred H Edwards, MD

  Society of Thoracic Surgeons

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: April 1, 2016
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-03